AstraZeneca: Divestment of rights to Alvesco, Omnaris and Zetonna to Covis

AstraZeneca has entered into an agreement with Covis Pharma B.V. (Covis Pharma) to sell its rights to the medicines Alvesco (ciclesonide), usedfor the treatment of persistent asthma, and Omnaris and Zetonna (ciclesonide), used for the treatment of nasal symptoms associated with rhinitis. The rights cover markets outside the US and the US royalties for the medicines. Covis Pharma currently commercialises Alvesco, Omnarisand Zetonna in the US and will become the owner of the medicines upon closing. The transaction does not include the transfer of any AstraZeneca employees or facilities.

Mark Mallon, Executive Vice President, Global Product and Portfolio Strategy, said: ‘One of our strategic objectives is to divest parts of our portfolio, allowing us to allocate resources to develop innovative new medicines to address unmet patient needs. Covis Pharma has strong capabilities in marketing medicines around the world, and our agreement with them means patients will continue to benefit from Alvesco, Omnaris and Zetonna.’

Michael Porter, Chief Executive Officer, Covis Pharma, said: ‘This is an exciting milestone for Covis Pharma and aligned with our strategy to build a global respiratory/allergy franchise. When we acquired the US rights for Alvesco, Omnaris and Zetonna in 2017, we recognised the importance of these medicines in the respiratory and allergy therapeutic area and we look forward to extending our reach to meet the needs of patients and physicians around the world.’

Alvesco is an inhaled anti-inflammatory maintenance therapy delivered by a metered-dose inhaler to help control persistent asthma. Omnaris and Zetonna are nasal sprays for the treatment of nasal symptoms associated with seasonal allergic and allergic/non-allergic perennial rhinitis. The active ingredient in all three medicines is ciclesonide, a synthetic corticosteroid that helps relieve inflammation.

Financial Considerations

Covis Pharma will pay AstraZeneca $350 million upon closing, in addition to conditional sales-related payments of up to $21 million over four years from 2019. The agreement is subject to customary closing conditions and is expected to complete by the end of 2018. As AstraZeneca will not maintain a significant ongoing interest in the medicines following completion, the payments will be recognised as Other Operating Income in the Company’s financial statements. Combined 2017 Product Sales of Alvesco, Omnarisand Zetonna,recorded by AstraZeneca, were $106 million. The agreement does not affect the Company’s financial guidance for 2018.

About Covis Pharma

Covis Pharma is headquartered in Zug, Switzerland and is a global speciality pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.

https://www.marketscreener.com/ASTRAZENECA-4000930/news/AstraZeneca-Divestment-of-rights-to-Alvesco-8232-Omnaris-and-Zetonna-to-Covis-Pharma-27552670/

Mylan’s profit beats; puts no timeline on strategic options

 Mylan NV beat analysts’ estimates for third-quarter profit on Monday, as the generic drugmaker reported higher sales of its products in emerging markets and said it had not set any timeline on evaluating its strategic alternatives.

The company’s shares rose 6 percent to $33.59 in after-market trading.

The EpiPen maker in August had set up a committee to review possible strategic alternatives, citing a tough U.S. environment for generic drugmakers.

“I can assure you the board is busy looking at lots of things… But we put no timeframes around that,” Chief Executive Officer Heather Bresch said on a post-earnings call.

U.S. generic drugmakers such as Mylan and Teva Pharmaceutical Industries Ltd have suffered over the past few years as a steep fall in generic prices weighed on their bottom lines.

However, Bresch on Monday said Mylan was seeing continued stabilization of the pricing environment.

The company said on Monday the U.S. Food and Drug Administration was in the final stage of reviewing the label of its generic version of GlaxoSmithKline Plc blockbuster asthma treatment Advair.

Winning approval would help assuage concerns about Mylan’s ability to execute on its complex generic pipeline portfolio, after it had twice failed to get FDA backing for Advair’s generic version.

“We continue to believe (the FDA) will be able to resolve outstanding issues very soon,” Mylan President Rajiv Malik said.

EpiPen revenue has declined over the last year on stiff competition, the launch of the company’s own cheaper generic and higher rebates that it has had to pay as a result of a settlement for overcharging the U.S. government.

Sales from the company’s ‘rest of the world’ unit, which caters to markets including China and Australia, rose 4 percent to $773.7 million in the reported quarter, boosted by its anti-retroviral therapy franchise.

Revenue from the North America unit, its biggest, fell 13.6 percent to $1.01 billion, mainly due to lower sales volumes of EpiPens and other products.

The company, which reaffirmed its full-year 2018 revenue and profit forecasts on Monday, said net earnings doubled to $176.7 million, or 34 cents per share, in the quarter ended Sept. 30.

On an adjusted basis, the company earned $1.25 per share. Total revenue fell 4 percent to $2.86 billion.

Analysts had expected the company to earn $1.19 per share on revenue of $2.91 billion, according to IBES data from Refinitiv.

https://www.marketscreener.com/MYLAN-NV-21077045/news/Drugmaker-Mylan-s-profit-beats-puts-no-timeline-on-strategic-options-27550693/

Comparing this Year’s Big Biotech IPOs to Previous Years

This year has been a strong one for biotech initial public offerings (IPO). In mid-September, there were 58, with the first listed on the BioPharmCatalyst database being Menlo Therapeutics on January 25, 2018. According to the Wall Street Journal, as of mid-October, 55 biotech companies had raised $5.75 billion. Obviously, the numbers depend somewhat on which database you check, but what is loud and clear is that 2018 has been a big one for biotech IPOs.

Several of this year’s biotech IPOs have been unusually large. Allogene Therapeutics, which was founded in 2017, raised $373 million in its IPO this year.

Rubius Therapeutics raised $277 million in its July IPO.

Homology Medicines raised $166 million in a March IPO and currently has a market value of more than $700 million.

Others include Tricida, which raised $22.3 million in June, Germany-based MorphoSys AG, which raised $207.8 million in April, Kiniksa Pharmaceuticals, which raised $152.6 million in May, and UK-based Autolus, which raised $150 million in June.

One reason it’s been such a big year for biotech IPOs is low interest rates and, Bloomberg wrote in September, “a hunt for higher returns by institutional investors.”

The Wall Street Journal suggests that accelerated approval modalities by the Food and Drug Administration (FDA) may be a factor. Perhaps investors see that as a possibility that potential drugs will make it to the market faster.

Biotech investment is different than, say, tech investment. One of the primary business models for biotech startups is getting to Phase I or Phase II clinical trials and either partnering with a large pharmaceutical company or being acquired by one. A typical strategy is raising funds to launch with a Series A, which will take the company through founding and preclinical trials. Another round, often Series B or later, will give it funds to take into early-stage trials, Phase I to get proof-of-concept, and sometimes into Phase II. Phase III trials are significantly more expensive due to their size and scope, which is why they often either team up with larger companies or try to raise even more money through an IPO.

For the last several years, BioSpace has selected a list of the top 20 Biotech Companies to watch, based on a number of metrics, including funds raised and innovation. A look at some of the top companies from these lists shows us a lot about IPOs.

Juno Therapeutics. Ranked number one on the NextGenBio Class of 2015, Juno’s initial Series A investment was $120 million. It held a secondary Series round in April 2014 with $176 million in fully committed funds. By the time it wrapped Series B, it had brought in more than $300 million in less than 12 months.

In December 2014, the company’s IPO climbed 60 percent at its debut, closing at $35 per share, raising $265 million from the offering. Its market valuation hit $2.7 billion in the opening day of trading. In January 2018, Celgene scooped up Juno for $9 billion.

MyoKardia. Ranked number two the same year as Juno topped the list, the company had raised $52 million in three rounds from a single investor, then brought in another $10 million in August 2014. Prior to its IPO, it raised about $75 million in venture funding. It launched an IPO in October 2015, pricing 5,437,500 shares at $10 per share for about $50.5 million. It had hoped to raise $91.6 million with the IPO.

Corvus Pharmaceuticals. Corvus ranked top of the list for 2016. It had raised $33.5 million in Series A, then another $75 million in Series B. In 2016 it priced its IPO at $15 per share, the lowest range it could. It raised $71 million rather than the $80 million it was aiming for.

CRISPR Therapeutics. Hitting number three on 2016’s list, CRISPR completed a $35 million Series A financing and an $89 million Series A and B round. In October 2016, CRISPR raised $56 million with its IPO. CRISPR was the third company focused on using CRISPR gene editing that year to file an IPO, following Editas Medicine, which raised more than $100 million in February and Intellia Therapeutics, which also raised more than $100 million. CRISPR Therapeutics’ take was about 25 percent lower than its target. (Editas ranked number 15 on BioSpace’s 2015 list.)

Denali Therapeutics. Hitting number one on the BioSpace Top 20 Life Science Startups to Watch in 2017, the company has always been a big money-raiser. It raised $347 million in venture capital funding in two rounds from five investors. Founded in May 2015 by three former Genentech researchers, in December 2017 its IPO raised $250 million shares priced at $18.

At the time, BioSpace wrote, “With the raise, the company’s market valuation is currently $1.7 billion. Not bad for a company that doesn’t have a product for sale and in the case of a biotech, is only just entering the clinic.”

It’s also worth noting that in 2017, the Denali IPO was the 40^thbiotech IPO of the year compared to only 27 in 2016.

Although this year’s boom appears to be slowing, that’s not completely unexpected. Hartaj Singh, an analyst with Oppenheimer, told Bloomberg in September, “We’ve already had a really good 12-month period. They don’t tend to be much longer than that.”

https://www.biospace.com/article/as-2018-hits-its-4th-quarter-biotech-ipos-continue/

NantKwest: Multiple Presentations at Immunotherapy of Cancer Conference

Update on Off-The-Shelf CD16 Targeted NK Cell (haNK) and NANT Cancer Vaccine Program Including Interim Data Analysis for Pancreatic Cancer, Triple Negative Breast Cancer & Head and Neck Cancer Trials

NantKwest (NASDAQ: NK), a leading, clinical-stage natural killer cell-based therapeutics company, today announced that the company will be making multiple presentations associated with the company’s off-the-shelf CD16 targeted NK cell (hanK) and NANT Cancer Vaccine platform at the upcoming Society for Immunotherapy of Cancer (SITC) Conference which runs from November 7 – 11 in Washington D.C.

SITC Conference Details:

Title:				First in human data in advanced solid tumors of NANT Cancer Vaccine: A novel temporospatial orchestration of the innate (NK) & adaptive immune system to induce antigen cascade & immunogenic cell death
Session:				Immune Escape: Currently Understanding of Mechanisms and Advances in Therapeutics Approaches
Date/Time:				Wednesday, November 7, 2018, 5:45pm EST
Type:				Oral Presentation
Title:				NANT Cancer Vaccine an orchestration of immunogenic cell death by overcoming immune suppression and activate NK and T cell therapy in patients with third-line or greater metastatic pancreatic cancer
Date:				Friday, November 9, 2018
Type:				Poster Presentation/Abstract #P713
Location:				Hall E
Title:				NANT Cancer Vaccine an orchestration of immunogenic cell death by overcoming immune suppression and activate NK and T cell therapy in patients with third-line or greater TNBC and head & neck cancer
Date:				Saturday, November 10, 2018
Type:				Poster Presentation/Abstract #P310
Location:				Hall E

https://www.biospace.com/article/releases/nantkwest-announces-multiple-presentations-at-the-2018-society-for-immunotherapy-of-cancer-conference/

Ascletis to Present Phase 2/3 All-oral Hep C Therapy Study at Liver Disease Meeting

Ascletis Pharma Inc.(1672.HK), a commercial-stage biotechnology company developing innovative drugs to address unmet needs in anti-viral, cancer and fatty liver disease therapeutic areas, announces today that a phase II / III clinical study of its all-oral HCV treatment (RDV/DNV Regimen) has been selected by AASLD’s Scientific Program Committee as a Poster Presentation. The presentation will be delivered at the 69th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), being held November 9-13, 2018, in San Francisco, CA. Prof. Lai Wei, the principal investigator of the study, will present the study at 14:00 PST, Nov. 12th. The presentation will be the first innovative direct-acting antiviral agent (DAA) developed by a Chinese company to be accepted by the annual meeting of AASLD.

In this multi-center, randomized, double blind, placebo-controlled phase II / III trial, named Efficacy and Safety of All-Oral, 12-Week Ravidasvir Plus Ritonavir-Boosted Danoprevir and Ribavirin in Treatment-naïve Non-Cirrhotic HCV Genotype 1 Patients: Results from a Phase 2/3 Clinical Trial inChina, a total of 424 treatment-naïve, non-cirrhotic adult HCV GT1 patients were enrolled and treated. The primary efficacy endpoint was the rate of sustained virologic response 12 weeks after the end of treatment (SVR12) and the safety was evaluated and compared between treatment and placebo groups. The results show that RDV/DNV Regimen demonstrated a cure rate of 99% (SVR12) with a short treatment duration of 12 weeks in treatment-naïve non-cirrhotic HCV genotype 1 Chinese patients. In patients with baseline NS5A resistance mutations, RDV/DNV Regimen demonstrated a cure rate of 100% (SVR12).

Ravidasvir is a next-generation, best-in-class and pan-genotypic HCV NS5A inhibitor with a high genetic barrier to resistance developed by Ascletis. Globally, Ravidasvir has completed three phase III clinical trials with more than 1,000 patients enrolled. Ravidasvir in combination with danoprevir is the first all-oral interferon-free HCV regimen developed by a domestic company in China. Danoprevir NDA was approved on June 8, 2018; Ravidasvir NDA was accepted by CFDA on August 1, 2018, and designated for Priority review on October 17, 2018, to shorten an approval timeline.

Details of presentation are listed below

Poster Title: “Efficacy and Safety of All-Oral, 12-Week Ravidasvir Plus Ritonavir-Boosted Danoprevir and Ribavirin in Treatment-Na.ve Non-Cirrhotic HCV Genotype 1 Patients: Results from a Phase 2/3 Clinical Trial in China”

Presenter: Prof. Lai Wei

Date and Time: 14:00 PST, Nov 12^th, 2018

Location: Moscone Center North/South Building, Hall C

https://www.biospace.com/article/releases/ascletis-to-present-phase-ii-iii-clinical-study-for-its-all-oral-hcv-treatment-at-the-69th-annual-meeting-of-aasld/

Ultragenyx to see a number of near-term catalysts, says Piper Jaffray

Piper Jaffray analyst Christopher Raymond kept his Overweight rating and $70 price target on Ultragenyx after its Q3 update marked the first full quarter of sales of Crysvita. The analyst notes that the launch has continued its momentum with other positive also coming from Mepsevii and its approval in all 28 E.U. countries and Brazil. Raymond further states that a number of near-term catalysts remain for Ultragenyx in 2018, such as the initial update on DTX401 in Glycogen storage disease, keeping a constructive view on the stock.

https://thefly.com/landingPageNews.php?id=2817968

Novartis’ Sandoz calls it quits on Rituxan biosimilar after FDA requests more data

Novartis’ Sandoz has already suffered one FDA rejection for its biosimilar version of Roche’s Rituxan, and now that the agency is requesting more data, the company is calling it quits.

Sandoz said Monday it won’t keep trying to win U.S. approval, even after the biosimilar won nods in Europe and several other markets. In a statement, Sandoz’s global biosim head Stefan Hendriks said the company believes “the patient and marketplace needs in the US will be satisfied” before Sandoz can generate the data the FDA wants.

“We are disappointed to have to make this decision and stand behind the safety, efficacy and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand and Australia,” Hendricks added.

Instead, Sandoz will focus its biosimilar efforts elsewhere. The company has seven global biosim approvals, including three in the U.S. It has a pending FDA submission on its biosim version of Amgen’s white blood cell booster Neulasta.

Meanwhile, Teva and Celltrion are advancing with their Rituxan biosimilar. Last month, an FDA panel unanimously backed the partners’ candidate, sending it to the FDA for a final say. If approved, Celltrion’s would be the first Rituxan biosim to secure a U.S. nod.

Under a marketing deal, Teva is set to sell that drug in the U.S. The company is “well positioned” to launch the biosim, according to Brendan O’Grady, Teva’s EVP of commercial operations in North America. Roche disclosed in its annual report that some of its Rituxan patent protections begin to expire this year.

Used to treat certain autoimmune diseases and cancers, Rituxan is a key performer for Roche as its top biologics increasingly face global biosimilar competition. Last year in the U.S., Rituxan generated more than $4 billion.

https://www.fiercepharma.com/pharma/sandoz-calls-it-quits-rituxan-biosim-candidate-after-fda-requests-more-data